A User Study With Vernivia® for Bacterial Vaginosis.
USV01
1 other identifier
interventional
76
1 country
7
Brief Summary
This is an open user study to evaluate D005 vagnial mousse with regards to user-friendliness, and measure time from start of treatment to symptom relief and measure the clarity of instructional material. The study will be conducted at seven sites in Sweden, the study population will consist of up to 100 female subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2021
CompletedFirst Submitted
Initial submission to the registry
September 2, 2021
CompletedFirst Posted
Study publicly available on registry
October 27, 2023
CompletedOctober 31, 2023
October 1, 2023
4 months
September 2, 2021
October 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate symptom relief during treatment with Vernivia®.
Evaluation of number of days from start of treatment until symptom relief
1-7 days
Secondary Outcomes (4)
Self-reported grading of malodorous discharge (0-3)
1-7 days
Net Promotor Score regarding user-friendliness
1-7 days
Clarity of the IFU (Instructions For Use)
1-7 days
Clarity of instructional video
1-7 days
Study Arms (1)
One dose daily for 7 consequtive days (dose acc to IFU)
OTHEROpen user study with Vernivia once daily for 7 consequtive days. Dosage according to IFU/Instructions For Use.
Interventions
D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
Eligibility Criteria
You may qualify if:
- Age 16 - 49 years Informed consent to take part in the study Bacterial vaginosis (based on self-assessment or diagnosed by a doctor or midwife) Access to a smartphone
You may not qualify if:
- Symptoms of vaginal candida infection and/or Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PepTonic Medical ABlead
- Key2Compliancecollaborator
- Replior ABcollaborator
Study Sites (7)
Mama Mia Väla
Väla, Helsingborg, 25467, Sweden
Mednika AB
Linköping, 58758, Sweden
Hälsomedicinskt Center
Lomma, 23439, Sweden
Mama Mia Barnmorskemottagning
Malmo, 21141, Sweden
Kvinnohälsan Stadsfjärden
Nyköping, 61131, Sweden
2Heal Medical
Stockholm, 11435, Sweden
Ondrasek Läkarmottagning
Sundsvall, 85230, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2021
First Posted
October 27, 2023
Study Start
April 1, 2021
Primary Completion
July 20, 2021
Study Completion
July 22, 2021
Last Updated
October 31, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share